MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM

Model Number 380990-11

Device Problems Electrical /Electronic Property Problem (1198); No Device Output (1435); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported problem.The illuminator was installed onto a test system and failed to power up the vision side cart with errors 297 and 48238.One burned fuse was found.Based on the information provided at this time, this complaint is being reported because of system unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.

Event Description

It was reported that during a da vinci assisted surgical procedure, error 48238 occurred.The customer power cycled the system; however, error 297 occurred.An isi technical support engineer had the customer confirm the led indicator on the front panel of the illuminator was not blue.The surgeon made the decision to convert the procedure to traditional laparoscopic techniques.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the illuminator to resolve error 297.The system was tested and verified as ready for use.The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.

• Brand Name: DAVINCI SI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer Contact: izabel nielson ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 8706352
• MDR Text Key: 150424357
• Report Number: 2955842-2019-10461
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380990-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1